Navelbine, good decision? - 1265360

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adrianm21
Navelbine, good decision? - 1265360

Hi

My mother has been diagnosed 2 years ago with NSCLC (pleural mets). Initially the cells were categorized as muciparous and for this type of cancer, as a first line treatment she was on Tarceva (on a study) for about 11 months, until progression of tumors. Then after, she was given a combination of Alimta and Cisplatin who proved to be effective for the past 10 months. However a new type of tumor has been developed (not muciparous), having a progression factor (KPI) 80%. The last CT proved that even though initially discovered tumor shrinked, the new type had spreaded and due to this, Alimta has been interrupted and my mother has been given Navelbine now (4x30 mg tablets once a week). However she is having serious abdominal pains and I wonder if this is/was the right treatment, the oncologist could have been prescribed her or was it a better option?
Could you please help out with your opinion?

Thanks in advance
Adrian

JimC
Reply To: Navelbine, good decision?

Hello Adrian,

Welcome to GRACE. I'm sorry to hear of your Mom's diagnosis, but it's good that her previous treatments provided some disease control.

No one here can advise you whether her abdominal pains are being caused by Navelbine, and for both legal and practical reasons, the doctors here cannot express an opinion about whether Navelbine is the best choice for her. That being said, it is almost never possible to say that a particular treatment choice is best for a specified patient. In any event, if a chosen treatment cannot be tolerated, a change is often indicated.

Here is a GRACE FAQ on second-line treatment, which shows that in general there are a number of appropriate options, including Navelbine, although it is less studied in that context than the leading FDA-approved choices (Tarceva, Alimta and Taxotere): http://cancergrace.org/lung/2010/10/04/lung-cancer-faq-2nd-line-nsclc-op...

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

Dr West
Reply To: Navelbine, good decision?

Actually, I've had a small number of pateints who have developed acute abdominal pain in the days after Navelbine. It's uncommon, but it's certainly possible (as are any of the other items on the long list of things that can cause belly pain.

Other options, such as Taxotere (docetaxel), which has a demonstrated survival benefit in previously treated patients, or gemcitabine, which has a less established role but is often well tolerated and may be a fair consideration.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

adrianm21
Reply To: Navelbine, good decision?

Hi

Thanks for your responses. She was given pills which caused her abdominal pains. Now the doctor switched to Navelbine injection. First problem I see:
these are given on weekly basis, which seems very often
my mother complains now about bone pains.
Could this be caused by the medicine itself or should we think about bone mets? If it's the second case, then is there a way to determine that clearly and are there any suplementary recommendations to shrink the bone mets (if presumably the pain is caused by those?).
Is Afatinib a good solution here, having in mind my mother has been confirmed with a mutation and she responded well to tarceva for a while as a first line treatment?

Thanks a lot in advance
Adrian

JimC
Reply To: Navelbine, good decision?

Hi Adrian,

I'm sorry to hear of the pain your mother is experiencing. Although bone mets could be the issue (and they can be detected with a PET scan or bone scan), the fact that the pain started shortly after starting Navelbine (Vinorelbine) suggests that it may be a side effect of the treatment, depending on where the pain is located. Navelbine is notorious for causing peripheral neuropathy, which Dr. West discussed here: http://cancergrace.org/cancer-treatments/2009/10/05/chemotherapy-induced... And Dr. Harman discussed some newer methods of treating it (and mentioned current interventions) here: http://cancergrace.org/cancer-treatments/2012/06/07/selected-asco-abstra... (scroll down to the section on neuropathy).

If bone mets are causing the pain, the treatment of choice is usually radiation, which can provide focused, relatively quick relief.

As you can see from these comments, Dr. West does not believe there is good evidence that Afatinib is effective after EGFR mutation-positive patients have developed acquired resistance:

As for using it in EGFR mutation-positive patients with acquired resistance, the data included in the press release is the definition of damning with faint praise. The response rate was under 10% in the best data they could dredge up in the world, and other experiences have been less favorable than not. There are no doubt rare patients who may benefit from it more than other EGFR TKIs, but every patient I’ve ever treated with afatinib after progressing on Tarceva has only experienced progression at the earliest scan afterward, along with greater toxicity than they ever had with Tarceva. Also, trials that have looked at Tarceva after Iressa or even progression after prior Tarceva and an interval off of it have experienced response rates comparable to what you see with afatinib.

[Continued in the next post]

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

JimC
Reply To: Navelbine, good decision?

[Continued from previous post]

So while I agree it’s an option to consider, I think it’s incorrect to infer or to believe any claims that it’s anything more than another EGFR TKI with comparable activity and greater toxicity than other options, except perhaps in very occasional patients. - http://cancergrace.org/topic/afatinib-approved-by-fda#post-1257889

On the other hand, later in the same thread Dr. West offered these comments about the combination of Afatinib and Cetuximab:

I’d distinguish my more pessimistic comments above from my perspective on the afatinib and cetuximab combination, which I think there’s more reason to be hopeful about. However, that work is still very early, and the side effect profile remains a very real concern as well think about broadening our experience with this regimen to a population of patients that don’t necessarily have the health, motivation, or resources to travel to the few sites offering the phase I/II trials. I look forward to seeing more research with this combination, but between now and then, I suspect it may be an uphill battle to get insurers to pay for cetuximab (and perhaps afatinib) outside of their approved settings, given their cost.

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

Dr West
Reply To: Navelbine, good decision?

Jim really unearthed the most relevant comments I'd have to make. I'm completely unimpressed with afatinib alone after Tarceva and don't think it merits being used anywhere near as much as it is, seemingly baed on a combination of reflex and desperation. I'm more hopeful about afatinib and cetuximab, though I think much more information is needed before we can really consider that a clear choice outside of a trial.

As for the question of pain in bones being related to the cancer or treatment, if it's in the same place(s) and steadily worsening, that's suggestive of it being a metastasis. If it waxes and wanes and isn't in the same place, that's less likely to be directly from the cancer.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

adrianm21
Hi

Hi

Very much appreciated your comments. We did an endoscopy which revealed there are no abdominal metastasis. We also intend to do a bone scan as suggested here above, to rule out the bone metastasis as well.
Now regarding your suggestions: Afatinib + Cetuximab, as far as I red, these come in a combination which has been studies by some medical associations, right? I mean they are made by different companies, hence I imagine the two companies didn't unite their forces to prove their drugs combined are effective. If this is correct, could you please help me out with some pointers on how to find the nearest city in Europe where I can try having my mom registered for such study? Does the study/trial has a name I can search for on clinical trials site?

Aside of these two, can Bavituximab Plus Docetaxel be a good option as a third line and/or third generation TKI?
See http://clinicaltrials.gov/show/NCT01999673

Thanks in advance
Adrian

JimC
Hi Adrian,

Hi Adrian,

The best place to find open clinical trials close to you is at clinicaltrials.gov, the site which you cited in your post. As Dr. West has written, there are plans to follow up the small preliminary trial of afatinib and cetuximab with a large, Phase III trial, but I don't see that listed yet: http://cancergrace.org/lung/2013/08/17/afatinib-for-acquired-resistance-...

Dr. West has written about the combination of Bavituximab and Docetaxel (Taxotere) here: http://cancergrace.org/lung/2012/09/18/bavituximab-gerber-trial/ As he states, although the results are encouraging, it was a small Phase II trial and too early to be certain it will be a real treatment advance.

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

Dr West
Yes, I don't have any

Yes, I don't have any additional information on where to pursue the combination of afatinib with cetuximab. Trials with this combination are not widely available at this time.

I consider the combination of bavituximab and docetaxel to be among the more appealing trial options out there, though still with undefined benefit compared with docataxel alone.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education